The Cancer Clinical Trials Office (CCTO) staffed by highly trained professional research personnel (research nurses, clinical research coordinators and clinical research associates), is a central office that provides the infrastructure and function for operations of Cancer Clinical Trials at Cedars-Sinai Cancer, including its medical network and health system, which at any given time has approximately 140 cancer clinical trials.
CCTO resources are available to both faculty and industry sponsors to assist throughout the lifecycle of a protocol, from inception to study closeout.
We are the central point of contact who coordinates with investigational pharmacy, laboratory, nursing, the National Cancer Institute (NCI) and other collaborating academic institutions.**We want you to join our team and use your skills with an organization known nationally for excellence in cancer research!**The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the main contact for the external sponsors.
Evaluates and abstracts research data and ensures compliance with protocol and research objectives.
Responsible for completing case report forms (CRFs), entering clinical research data, and assisting with regulatory submissions to the IRB.
Provides limited patient contact with research participants as needed for study and assist with study budget and patient research participant research billing.
In addition, the CRA II may coordinate activities, training, and education for other Clinical Research Associates.**Essential Job Duties:**+ Independent study coordination including screening of prospective patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.+ Scheduling of patients for research visits and procedures.+ In collaboration with the physician and other medical personnel, documents detailed CRFs: changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.+ Maintains accurate source documents related to all research procedures.+ Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.+ Schedules and participates in monitoring and auditing activities.+ Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at routine research staff meetings.+ Updates direct supervisor about concerns regarding data quality and study conduct.+ Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.+ May involve other regulatory / IRB duties, budgeting duties, and helping with patient research billing and reconciliation.+ Confirms compliance with all federal and local agencies including the Food and Drug Administration (FDA and local IRB).+ Maintains research practices using Good Clinical Practice (GCP) guidelines.+ Maintains strict patient confidentiality according to HIPAA regulations and applicable law.+ May coordinate and participate in training and education of other personnel.+ May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.+ May plan and coordinate strategies for growing patient enrollment, and/or improving clinical research efficiency.+ May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to enhance quality.+ May identify new research opportunities and present to investigator.**Education:**+ BA/BS degree.**License/Certification/Registration Requirements:**+ ACRP/SoCRA (or equivalent) certification preferred.**Experience:**+ Two (2) years of directly related experience, or equivalent combination of education and experience.Cedars-Sinai is an EEO employer.
Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.